Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

KTI 2022-08-25

Compass Steerable Needle

Applicant Serpex Medical, Inc.

K-Number K221206

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LYY 2022-08-25

Iconic Latex Glove

Applicant Iconic Medicare Sdn Bhd

K-Number K221648

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MXD 2022-08-25

LINQ II Insertable Cardiac Monitor

Applicant Medtronic, Inc.

K-Number K221962

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NVE 2022-08-25

AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector

Applicant Steris

K-Number K222543

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GCJ 2022-08-25

LapBox Tissue Containment Removal System

Applicant Ark Surgical, Ltd.

K-Number K221365

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LZA 2022-08-25

Nitrile Exam Gloves (Blue, Black)

Applicant Hebei Astro Medical Supply Co., Ltd.

K-Number K221143

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PBX 2022-08-25

Apollo Duet (Model : APD-4000)

Applicant Weero Co.

K-Number K212253

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OSN 2022-08-25

Acute QC Strut and Components

Applicant Smith & Nephew, Inc.

K-Number K221792

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NGX 2022-08-25

WiEMSpro

Applicant Medical Cables S.L.

K-Number K211298

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OBP 2022-08-24

NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health

Applicant Neuronetics, Inc.

K-Number K222230

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QKB 2022-08-24

AutoContour Model RADAC V2

Applicant Radformation, Inc.

K-Number K220598

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FXX 2022-08-24

The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask

Applicant The Good Corporation

K-Number K211771

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